(SLB-015) Multiple Sclerosis Disease-Modifying Therapies and Human Papillomavirus-Related conditions: a disproportionality analysis from the WHO Vigibase

Background: Second-generation multiple sclerosis disease-modifying therapies (MS-DMTs) are associated with heightened immunosuppressive effects, potentially increasing the risk of infections. However, their association with human papillomavirus (HPV)-related conditions remains underexplored, particularly for newer treatments.

Objectives: This study aimed to evaluate the risk of HPV-related conditions associated with MS-DMTs using real-world pharmacovigilance data.

Methods: Individual case safety reports (ICSRs) from Vigibase®, the WHO global pharmacovigilance database, were analyzed for MS-DMTs from January 1, 2000, to December 31, 2023. Disproportionality analysis was performed to calculate adjusted reporting odds ratios (aRORs) and 95% confidence intervals (CIs) for HPV-related conditions associated with each MS-DMT.

Results: Among 418,182 ICSRs involving MS-DMTs, 1,111 reported HPV-related conditions. Fingolimod demonstrated the highest adjusted ROR of 3.35 (95% confidence interval [CI] 2.86–3.92), followed by ocrelizumab (2.36 [1.81–3.03]) and natalizumab (1.36 [1.13–1.62]) compared to pegylated or non-pegylated interferon betas. Second-generation MS-DMTs collectively showed a higher risk of HPV-related conditions than first-generation therapies (aROR 2.30, 95% CI 2.04–2.59).

Conclusions: This study identified an increased risk of HPV-related conditions associated with fingolimod, ocrelizumab, and natalizumab based on real-world pharmacovigilance data. These findings highlight the importance of HPV vaccination and enhanced cervical cancer screening for patients treated with these MS-DMTs. Further pharmacoepidemiological research is warranted to confirm these associations and inform clinical guidelines.